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Treating South African Pregnant Women for Methamphetamine

Treating South African Pregnant Women for Methamphetamine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01386138
Enrollment
60
Registered
2011-06-30
Start date
2011-07-31
Completion date
2013-06-30
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Drug Addiction

Keywords

HIV, HIV Risk, Sexually Transmitted Infections, Women, Pregnancy, Neonatal Health, Drug Use, Drug Treatment, Gender-specific Treatment, Methamphetamine, Opioids, Cocaine, Injection Drugs, Stimulants, Alcohol, Mandrax, Marijuana, Nicotine

Brief summary

The purpose of this study was to develop and initially evaluate an efficacious, comprehensive, culturally sensitive, women-centered model of care for pregnant South African women by adapting and refining PI Jones' Reinforcement-Based Treatment (RBT) model, at the same time integrating into it the HIV prevention components of Co-I Wechsberg's Women's Health CoOp (WHC) model, yielding an integrated treatment and prevention model, RBT+WHC.

Detailed description

Cape Town is a striking example of the need for women-specific substance abuse treatment, as it is experiencing a devastating level of methamphetamine use (7% of the adult population),especially among women of childbearing age. The use of methamphetamine (hereafter referred to as meth) is higher in Cape Town than anywhere else in the country. Consequently, there has been a critical need to develop and test a woman-focused intervention that reduces meth use in a highly vulnerable population of South African women. Since 2001, the Women's Health CoOp (WHC; PI Wechsberg; RO1s DA011609S; AA014488; HD058320) has successfully adapted an evidence-based intervention to reduce sex- and drug-risk behaviors in drug-using South African women. However, with a rapid rise in meth use, the Western Cape is experiencing a new drug epidemic. A previous WHC study data indicated that the WHC had limited success in reducing the use of this among women. Alarmingly, among WHC participants, a greater proportion of pregnant than non-pregnant women reported using meth (n=24/26=92%; n=238/356=67%; p=.01). These findings are underscored by a lack of a focused and intensive treatment for meth-using pregnant women who live in impoverished townships. Thus, this project responded to PA-09-021 International Research Collaboration on Drug Abuse and Addiction Research (R21) by developing treatment options for meth use among pregnant women and using the long collaboration between WHC staff and local treatment providers to develop our first project to treat meth use in pregnant women. The goal of this project was to develop and initially evaluate an efficacious, comprehensive, culturally sensitive, women-centred model of care for pregnant South African women by adapting and refining PI Jones' Reinforcement-Based Treatment (RBT) model, at the same time integrating into it the HIV prevention components of Co-I Wechsberg's Women's Health CoOp (WHC) model, yielding an integrated treatment and prevention model, RBT+WHC. The study had two sequential aims: Aim 1: Adapt and pretest a comprehensive drug abuse treatment model, RBT, which integrated the evidence-based WHC HIV prevention model, to produce a comprehensive, culturally sensitive, woman-focused intervention for meth-using pregnant Coloured women, RBT+WHC. Aim 2: Conduct a small-scale randomized controlled trial (RCT) with pregnant Coloured women to determine the acceptability, feasibility, and initial efficacy of the RBT+WHC model relative to a psycho-educational control condition in terms of their respective impact on maternal outcomes, including (a) meth use, (b) frequency of unprotected sex acts, and (c) number of prenatal care visits; and neonatal outcomes including (d) length of hospital stay, (e) birth weight, and (f) gestational age at delivery. About 300 women were screened for the study but only 32 were found to eligible and completed the study. The public health impact of this project was far-reaching. RBT+WHC aimed to fill a critical gap in substance use treatment research in a social structure where women are disproportionately disenfranchised from receiving healthcare compared with men. Furthermore, this initial study laid the foundation for a full-scale RCT to examine the impact of RBT+WHC on an array of maternal and neonatal outcomes, within the population of pregnant Coloured as well as Black and White South African women.

Interventions

Receive RBT education and peer-support in a group format.

BEHAVIORALExperimental

Receive RBT education and a pro-active counseling method

Sponsors

University of Cape Town
CollaboratorOTHER
RTI International
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* are 18 years of age or older * self-identify as Coloured (this is a cultural grouping of people with mixed-race ancestry) * live in the Cape Town township communities of Mitchell's Plain, Delft, Elsie's River, Belhar, Bishop Lavis, or Ravensmead * meet current DSM-IV criteria for methamphetamine abuse or dependence * are willing to enter drug abuse treatment * report unprotected sex in the past 30 days * are HIV negative * provide verifiable locator information for follow-up interview * are 20-28 weeks pregnant, inclusive, and determined by last menstrual period

Exclusion criteria

* are male * are younger than 18 years * do not self-identify as Coloured * do not live in the Cape Town township communities of Mitchell's Plain, Delft, Elsie's River, Belhar, Bishop Lavis, or Ravensmead * do not meet current DSM-IV criteria for methamphetamine abuse or dependence * are not willing to enter drug abuse treatment * have not reported unprotected sex in the past 30 days * are HIV positive * do not provide verifiable locator information for follow-up interview * are not 20-28 weeks pregnant * are not able to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Methamphetamine practices3 months after randomizationFrequency of methamphetamine use in past 30 days measured by RRBA (WHC Revised Risk Behavior Assessment) and urine test
Prenatal careAt time of deliveryNumber of prenatal care visits measured by chart review of hospital record
Length of hospital stayAt time of deliveryLength of hospital stay measured by chart review of hospital record

Secondary

MeasureTime frameDescription
Sexual practices3 months after randomizationFrequency of unprotected sexual acts at last sexual encounter and in past 30 days measured by RRBA
Drug Use3 months after randomizationFrequency of opioid, cocaine, mandrax, marijuana, and self-report nicotine use in past 30 days measured by RRBA (WHC Revised Risk Behavior Assessment) and urine test
Estimated gestational ageAt time of deliveryEstimated gestational age measured by chart review of hospital record
BirthweightAt time of deliveryBirthweight measured by chart review of hospital record
Drug and alcohol use composite scores3 months after randomizationDrug and alcohol composite scores measured by the Addiction Severity Index
Alcohol use3 months after randomizationFrequency of alcohol use in past 30 days measured by RRBA and breath test

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026